Bardex® Lubricath® Foley Catheter 0165L16Recalls & reported problems
C. R. Bard, Inc. · Bardex® Lubricath® Foley Catheter 5cc Balloon Lubricious Coated · Class 2
All models of Bardex Lubricath Foley Catheter (38)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bardex Lubricath Foley catheter from Bard is a tube inserted into the bladder to drain urine. The FDA database holds 544 reports, many describing balloons that tear, leak or fail to inflate or deflate, with 36 injuries and no deaths. No recalls name this device. Reports fell from 152 in the previous 12 months to 87 in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 539
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 539 adverse event reports that list this exact device (DI 00801741017483), received between May 10, 2017 and Sep 28, 2026 — classified as 34 injuries, 505 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (83 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Puncture/Hole83
- Material Rupture68
- Partial Blockage65
- Difficult to Remove59
- Deflation Problem49
- Inflation Problem45
- Fluid/Blood Leak37
- Inaccurate Flow Rate30
Patient problems
- No Clinical Signs, Symptoms or Conditions360
- No Consequences Or Impact To Patient102
- No Known Impact Or Consequence To Patient61
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available18
- Urinary Retention9
- Urinary Tract Infection8
- Discomfort7
- Pain7
Recent adverse event reports
The 25 most recent of 539 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924434 ↗MalfunctionSep 28, 2026Material Rupture
Patient problems: Pain
MAUDE report 50916290 ↗MalfunctionSep 26, 2026Inaccurate Flow Rate
Patient problems: Pain; Urinary Retention
MAUDE report 50908456 ↗MalfunctionSep 25, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903554 ↗MalfunctionSep 11, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741621 ↗MalfunctionSep 11, 2026Difficult to Remove
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50739945 ↗MalfunctionSep 9, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702129 ↗MalfunctionAug 28, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50501989 ↗MalfunctionAug 25, 2026Material Rupture
It was reported that during use Foley catheter was inserted on (b)(6) and the Foley catheter had spontaneously dislodged by the 20th. Upon inspection of the dislodged catheter, the balloon section was found to be torn. Balloon rupture incident.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50427840 ↗MalfunctionAug 21, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50382775 ↗MalfunctionAug 14, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50256585 ↗MalfunctionAug 6, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50161550 ↗MalfunctionAug 4, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50135455 ↗MalfunctionJul 15, 2026Material Puncture/Hole
IT WAS REPORTED THAT AFTER INSERTION, THE FOLEY CATHETER CAME OUT NATURALLY AND STERILE WATER LEAKED, SO WHEN CHECKED, A PINHOLE WAS FOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25830555 ↗MalfunctionJul 10, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25788055 ↗MalfunctionJul 10, 2026Material Rupture
It was reported that during placement rupture occurred at the tip of the catheter in the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25786729 ↗MalfunctionJul 9, 2026Material Rupture
IT WAS REPORTED THAT DURING USE, FOLEY CATHETER BALLOON HAD BURST, AND THE CATHETER EXPELLED AND WAS ABLE TO SEE VISIBLE SLIT IN CATHETER BALLOON. UNFORTUNATELY, DO NOT HAVE PICTURES OF THE CATHETER. THE PATIENT HAS ALSO REQUIRED MULTIPLE CATHETER CHANGES OVER THE LAST 3-4 MONTHS DUE TO BALLOONS BURSTING; EACH CATHETER WAS CHECKED FOR DIFFERENT LOT NUMBERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25763754 ↗MalfunctionJun 30, 2026Material Rupture
IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER BALLOON HAD BURST AND THE CATHETER EXPELLED AND WAS ABLE TO SEE VISIBLE SLIT IN CATHETER BALLOON. THE CATHETER WAS REPLACED AND ENSURED PROVIDED DIFFERENT LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25669498 ↗MalfunctionJun 25, 2026Positioning Failure; Component Misassembled
IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER HAD NO EYE OPENINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25620795 ↗MalfunctionJun 19, 2026Component Misassembled; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING USE THERE WAS NO HOLE AT THE TIP OF THE FOLEY CATHETER, SO URINE COULD NOT FLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25563766 ↗MalfunctionJun 4, 2026Material Rupture
IT WAS REPORTED THAT DURING PLACEMENT HOLE DEVELOPED IN THE BALLOON WHILE THE CATHETER WAS IN PLACE. PATIENT HAD BLADDER STONES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25392345 ↗MalfunctionJun 2, 2026Disconnection
IT WAS REPORTED THAT DURING WATER FILLING VALVE CAME LOOSE AS VALVE WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25367852 ↗MalfunctionMay 28, 2026Material Rupture
IT WAS REPORTED THAT BALLOON HAD BURST IN LAST 3 FOLEY CATHETERS. THAT CAUSED CATHETER TO BE CHANGED MUCH EARLIER THAN NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25317482 ↗MalfunctionMay 22, 2026Disconnection; Material Puncture/Hole
IT WAS REPORTED THAT WHEN THE FOLEY CATHETER WAS INSERTED INTO PATIENT, THE BALLOON WAS INFLATED, BUT THE CUFF FELL OFF THE END OF THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25261449 ↗MalfunctionMay 10, 2026Deflation Problem; Difficult to Remove
IT WAS REPORTED THAT DURING USE THE CATHETER WAS NOT DEFLATING WHEN BEING USED ON A PATIENT DURING A PROCEDURE AND THE PRODUCT HAD TO BE REMOVED BY CUTTING THE ITEM FROM OUTSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133577 ↗
Other CATHETER, COUDE devices
- Bardex® Lubricath® Foley Catheter 0165L14C. R. Bard, Inc. · CATHETER, COUDE562 reports
- Bardia® Foley Catheter Silicone Coated 123516AC. R. Bard, Inc. · CATHETER, COUDE381 reports
- Bardia® Foley Catheter Silicone Coated 123514AC. R. Bard, Inc. · CATHETER, COUDE195 reports
- SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A899916C. R. Bard, Inc. · CATHETER, COUDE3 recalls19 reports
- Bardia® Foley Catheter Silicone Coated 123518AC. R. Bard, Inc. · CATHETER, COUDE153 reports
- SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A902916C. R. Bard, Inc. · CATHETER, COUDE2 recalls50 reports
- Bard® Lubricath® Foley Catheter 365716C. R. Bard, Inc. · CATHETER, COUDE117 reports
- SureStep™ Foley Tray System Bard® Lubricath Foley A800365C. R. Bard, Inc. · CATHETER, COUDE2 recalls12 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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